[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19293-19294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7767]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0293]


Orthopaedic and Rehabilitation Devices Panel of the Medical 
Devices Advisory Committee; Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: This notice announces a forthcoming meeting of a public 
advisory committee of the Food and Drug Administration (FDA) to discuss 
current knowledge about the safety and effectiveness of Metal-on-Metal 
(MoM) hip arthroplasty systems. FDA is convening this committee to seek 
expert scientific and clinical opinion on the risks and benefits of 
these types of devices based on available scientific data. The meeting 
will be open to the public.

DATES: The meeting will be held on June 27 and 28, 2012, from 8 a.m. to 
7 p.m. FDA is opening a docket to allow for public comments to be 
submitted to the Agency on the issues before the Orthopaedic and 
Rehabilitation Devices Panel of the Medical Devices Advisory Committee. 
Submit either electronic or written comments by May 9, 2012.

ADDRESSES: Meeting location is to be determined (TBD). Prior to the 
meeting, FDA will announce the meeting location in a future Federal 
Register notice. We will also provide the meeting location on FDA's 
Advisory Committee Information line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area) and on the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

FOR FURTHER INFORMATION CONTACT: Avena Russell, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-796-3805, 
[email protected], or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow 
the prompts to the desired center or product area. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Name of Committee: Orthopaedic and Rehabilitation Devices Panel of 
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Agenda: On June 27 and 28, 2012, the committee will discuss current 
knowledge about the safety and effectiveness of Metal-on-Metal (MoM) 
hip arthroplasty systems. FDA is convening this committee to seek 
expert scientific and clinical opinion on the risks and benefits of 
these types of devices based on available scientific data.
    Hip arthroplasty is intended to provide increased patient mobility 
and reduce pain by replacing the damaged hip joint articulation in 
patients where there is evidence of sufficient sound bone to seat and 
support the components.
    There are two categories of metal-on-metal hip arthroplasty 
systems:
    1. Metal-on-Metal total hip replacement (THR) systems consist of a 
metal ball (femoral head), a metal femoral stem in the thighbone, and a 
metal cup in the hip bone (acetabular component). MoM THR systems are 
typically indicated for use in total hip arthroplasty in skeletally 
mature patients with the following conditions:
    a. Non-inflammatory degenerative joint disease (NIDJD) such as 
osteoarthritis, avascular necrosis, post-traumatic arthritis, 
ankylosis, protrusio acetabuli, and painful hip dysplasia;
    b. Inflammatory degenerative joint disease such as rheumatoid 
arthritis;
    c. Correction of functional deformity; and,
    d. Revision procedures where other treatments or devices have 
failed.
    2. Metal-on-Metal hip resurfacing systems consist of a trimmed 
femoral head capped with a metal covering and a metal cup in the hip 
bone (acetabular component). Hip resurfacing arthroplasty is intended 
for reduction or relief of pain and/or improved hip function in 
skeletally mature patients having the following conditions:
    a. Non-inflammatory degenerative arthritis such as osteoarthritis, 
traumatic arthritis, avascular necrosis, or dysplasia/developmental 
dislocation of the hip (DDH); or
    b. Inflammatory arthritis such as rheumatoid arthritis.
    Resurfacing systems are intended for patients who, due to their 
relatively younger age or increased activity level, may not be suitable 
for traditional total hip arthroplasty due to an increased possibility 
of requiring ipsilateral hip joint revision.
    In February 2011, FDA published a Web site on MoM total and 
resurfacing hip systems with information for orthopedic surgeons and 
for patients with or considering hip replacement (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/default.htm).
    Numerous recent publications, studies and registry reports have 
raised safety concerns for MoM THRs. In February 2012, the United 
Kingdom's (UK) Medicines and Healthcare products Regulatory Agency 
(MHRA) published a Medical Device Alert with updated advice on the 
management and monitoring of patients implanted with MoM hip systems 
recommending more aggressive followup of patients with larger THR 
systems (>=36 millimeter (mm)). Further information about actions taken 
by MHRA, with links to information about MoM hip implants for patients 
and healthcare professionals, is available on their Web site at http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Metal-on-metalhipimplants/index.htm. (FDA has verified the Web site address, but 
we are not responsible for any subsequent changes to the Web site after 
this document publishes in the Federal Register.)
    In December 2011, the American Academy of Orthopedic Surgeons 
(AAOS) published an overview on MoM hip systems (total and resurfacing) 
(Ref. 1). The AAOS overview provides a summary of clinical outcomes in 
patients with MoM hip systems in comparison to other bearing surface 
combinations, addresses patient, implant and surgical factors that may 
predict successful/unsuccessful outcomes of MoM hip systems and 
discusses the prevalence of adverse clinical problems from MoM hip 
systems in comparison to other bearing surface combinations. One item 
referenced in the report is the Australian registry, which reported 
higher revision rates for patients with implants that have large-
diameter heads (>=28 mm) (Ref. 2).
    While current data are highly suggestive that a large percentage of 
patients with MoM hip systems have successful outcomes, a recent 
scientific publication raised serious concerns about the failure rates 
of MoM hip

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systems for the UK population (Ref. 3). This peer-reviewed journal 
article presented the following findings regarding primary MoM THR: (1) 
Increased failure rate at 5 years for MoM THR related to larger head 
sizes; (2) significantly higher risk for revision in female patients 
(Note: In the United States, labeling discourages use of MoM hips in 
females of child bearing age with warnings in MoM THR labeling and 
contraindications in MoM hip resurfacing labeling); and (3) revisions 
for dislocation in men with MoM replacements were slightly lower, 
showing some benefit to larger head sizes.
    The committee will be asked to discuss the following as it pertains 
to these devices in the U.S. population: Device mechanisms of failure, 
metal ion testing, imaging methods, local and systemic complications, 
preoperative and postoperative patient risk factors, as well as 
clinical followup considerations for patients with MoM hip systems 
(total and resurfacing).
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: FDA will work with affected industry, professional 
organizations, and societies that have an interest in the MoM hip 
arthroplasty systems and who wish to make a presentation separate from 
the general open public hearing; time slots on June 28, 2012, between 
approximately 9 a.m. and 10 a.m. Representatives from industry, 
professional organizations and societies interested in making formal 
presentations to the committee should notify the contact person on or 
before May 1, 2012.
    Interested persons may present data, information, or views, orally 
or in writing, on issues pending before the committee. Written 
submissions may be made to the contact person on or before May 9, 2012. 
On June 27, 2012 oral presentations from the public will be scheduled 
between approximately 9 a.m. and 10 a.m. Those individuals interested 
in making formal oral presentations should notify the contact person 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before May 1, 2012. Time allotted for 
each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by May 2, 2012.
    Comments: FDA is opening a docket to allow for public comments to 
be submitted to the Agency on the issues before the Orthopaedic and 
Rehabilitation Devices Panel of the Medical Devices Advisory Committee 
beginning on March 30, 2012, and closing on May 9, 2012. Interested 
persons are encouraged to use the docket to submit electronic or 
written comments regarding this meeting. Submit electronic comments to 
http://www.regulations.gov. Submit written comments to the Division of 
Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact James Clark, 
[email protected] or 301-796-5293 at least 7 days in advance of 
the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

I. References

    The following references have been placed on display in the 
Division of Dockets Management (see Comments) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web site after this document 
publishes in the Federal Register.)

1. American Academy of Orthopedic Surgeons, ``Modern Metal-on-Metal 
Hip Implants: A Technology Overview'' (July 15, 2011), accessed 
online at http://www.aaos.org/research/overviews/Metal_On_Metal.pdf.
2. Adelaide: Australian Orthopaedic Association, Australian 
Orthopaedic Association National Joint Replacement Registry: Annual 
Report 2010, 2010.
3. Smith, A.J., P. Dieppe, K. Vernon, et al., ``Failure Rates of 
Stemmed Metal-on-Metal Hip Replacements: Analysis of Data From the 
National Joint Registry of England and Wales,'' Lancet (March 13, 
2012), accessed online at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60353-5/fulltext#article--upsell 
(doi:10.1016/S0140-6736(12)60353-5).

    Dated: March 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7767 Filed 3-29-12; 8:45 am]
BILLING CODE 4160-01-P